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The Bioabsorbable Anchor is indicated for the fixation of soft tissue grafts in various minimally invasive and open orthopedic surgical procedures in shoulder.

The Bioabsorbable Anchor is an absorbable implant device that is intended to provide fixation of a prosthetic material to soft tissue and/or bone. The Bioabsorbable Anchor is composed of polydioxanone (PDO) dyed with D&C Violet No. 2. Two Bioabsorbable Anchors are provided sterile for single use only, packaged preloaded in a disposable anchor inserter instrument, the Dual Anchor Inserter. The preloaded Dual Anchor Inserter is provided in a dual sterile pouch confiquration.

The provided text discusses a 510(k) premarket notification for a medical device called the "Bioabsorbable Anchor." It details the device's description, indications for use, comparison to a predicate device, and performance data required for substantial equivalence determination.

However, the document does not contain information regarding the acceptance criteria and study proving the device meets those criteria in the context of an AI/human-in-the-loop setting, as implied by the detailed questions about sample sizes, expert ground truth, MRMC studies, and standalone algorithm performance.

The "Performance Data" section of the document specifically outlines:

• Biocompatibility Testing: Conducted in accordance with ISO 10993 standards.
• Non-Clinical Performance Testing: Included insertion, pullout, and fatigue testing, evaluated in comparison to the predicate device and guided by FDA guidance for "Bone Anchors."
• In vitro hydrolytic degradation study: Guided by ASTM F1635-16.
• Absorption Profile: Describes the hydrolytic degradation and tissue response after 13 weeks.

These tests are primarily mechanical, material, and biological evaluations relevant to the physical performance and safety of an implantable device, not an AI/software device that requires extensive clinical validation with human readers or standalone algorithm performance metrics like sensitivity, specificity, or AUC based on expert ground truth.

Therefore, I cannot extract the information required to answer your specific questions from the provided text as it pertains to a different type of medical device evaluation.

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